RE:"...is currently working with the FDA..."toade1313 wrote
In the Oct 22nd PR it states.."The Company has submitted Food and Drug Administration Investigational New Drug (IND) application and is currently working with the FDA in the approval of the IND to allow the Company to launch clinical Study II sites in the US." To me that means there was a response from the FDA and no automatic 30 calendar day approval is in play. How do others read that statement?
Hi toade1313 ... I will assume there isn't a problem only because if there were it would be considered a material event and being such Theralase would have to release to the public stating so. News releases in the past have said the company was working with the FDA to make sure all went smooth so they wouldn't encounter any problems and would have continuous communication.